The trial will assess REZLIDHIA plus decitabine and venetoclax in patients with mutated isocitrate dehydrogenase-1 acute myeloid leukemia. Credit: Yomal2233/Shutterstock.

Rigel Pharmaceuticals has announced the enrolment of the first subject in a Phase Ib/II clinical trial of REZLIDHIA (olutasidenib) in combination with decitabine and venetoclax for patients with mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukaemia (AML).

The multicentre, open-label, non-randomised study is sponsored and being carried out by The University of Texas MD Anderson Cancer Center (MD Anderson) in the US.

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The initial Phase Ib portion of the trial aims to establish the safety, tolerability, and recommended Phase II dose of oral or intravenously administered (IV) decitabine and venetoclax plus olutasidenib in mIDH1 R/R patients.

Following Phase Ib, the Phase II part of the trial will involve 60 patients.

This portion will focus on determining the complete remission rate among both newly diagnosed and relapsed/refractory (R/R) mIDH1 AML patients as its primary objective.

REZLIDHIA is an oral small-molecule inhibitor targeting mIDH1, designed to reduce 2-hydroxyglutarate levels and promote normal differentiation of myeloid cells.

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It is currently approved for treating R/R mIDH1 AML.

This trial is said to be the first under the multi-year strategic alliance between Rigel and MD Anderson.

Under the strategic alliance, Rigel and MD Anderson will further assess olutasidenib’s potential in combination with other agents for treating various haematologic neoplasms, including newly diagnosed and R/R AML, advanced myeloproliferative neoplasms (MPN) and higher-risk myelodysplastic syndromes (MDS).

Additionally, the collaboration will explore the use of olutasidenib as a single agent in conditions such as lower-risk MDS, clonal cytopenia of undetermined significance (CCUS), and as a maintenance treatment post-haematopoietic stem cell transplant.

Rigel Pharmaceuticals president and CEO Raul Rodriguez said: “We believe REZLIDHIA has strong potential in a wide range of cancers where mIDH1 plays an important role. Studying REZLIDHIA in combination with two widely used agents in AML could provide a new all-oral front-line option to patients who are in urgent need of innovative treatments.

“MD Anderson is the ideal partner on this journey to evaluate REZLIDHIA’s impact on AML and other haematological cancers.”

In January 2024, Rigel signed a partnership with CONNECT, the international network of paediatric cancer centres, to initiate a Phase II clinical trial of REZLIDHIA in newly diagnosed paediatric and young adult patients with high-grade glioma (HGG).